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WO2015066356A1 - Cartouche de produit pour radionucléide - Google Patents

Cartouche de produit pour radionucléide Download PDF

Info

Publication number
WO2015066356A1
WO2015066356A1 PCT/US2014/063209 US2014063209W WO2015066356A1 WO 2015066356 A1 WO2015066356 A1 WO 2015066356A1 US 2014063209 W US2014063209 W US 2014063209W WO 2015066356 A1 WO2015066356 A1 WO 2015066356A1
Authority
WO
WIPO (PCT)
Prior art keywords
cartridge
filling
product
radionuclide
shield
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2014/063209
Other languages
English (en)
Inventor
Glenn H. ISENSEE
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Northstar Medical Radioisotopes LLC
Original Assignee
Northstar Medical Radioisotopes LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Northstar Medical Radioisotopes LLC filed Critical Northstar Medical Radioisotopes LLC
Priority to CN201480060079.5A priority Critical patent/CN105682705B/zh
Priority to DK14857442.9T priority patent/DK3062840T3/en
Priority to CA2928837A priority patent/CA2928837C/fr
Priority to EP14857442.9A priority patent/EP3062840B1/fr
Priority to KR1020167014448A priority patent/KR102333352B1/ko
Priority to AU2014342231A priority patent/AU2014342231B2/en
Priority to JP2016552243A priority patent/JP6657102B2/ja
Publication of WO2015066356A1 publication Critical patent/WO2015066356A1/fr
Priority to ZA2016/02674A priority patent/ZA201602674B/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • G—PHYSICS
    • G21—NUCLEAR PHYSICS; NUCLEAR ENGINEERING
    • G21F—PROTECTION AGAINST X-RADIATION, GAMMA RADIATION, CORPUSCULAR RADIATION OR PARTICLE BOMBARDMENT; TREATING RADIOACTIVELY CONTAMINATED MATERIAL; DECONTAMINATION ARRANGEMENTS THEREFOR
    • G21F5/00—Transportable or portable shielded containers
    • G21F5/015—Transportable or portable shielded containers for storing radioactive sources, e.g. source carriers for irradiation units; Radioisotope containers
    • G—PHYSICS
    • G21—NUCLEAR PHYSICS; NUCLEAR ENGINEERING
    • G21F—PROTECTION AGAINST X-RADIATION, GAMMA RADIATION, CORPUSCULAR RADIATION OR PARTICLE BOMBARDMENT; TREATING RADIOACTIVELY CONTAMINATED MATERIAL; DECONTAMINATION ARRANGEMENTS THEREFOR
    • G21F5/00—Transportable or portable shielded containers
    • G21F5/06—Details of, or accessories to, the containers
    • G21F5/12—Closures for containers; Sealing arrangements
    • G—PHYSICS
    • G21—NUCLEAR PHYSICS; NUCLEAR ENGINEERING
    • G21G—CONVERSION OF CHEMICAL ELEMENTS; RADIOACTIVE SOURCES
    • G21G1/00—Arrangements for converting chemical elements by electromagnetic radiation, corpuscular radiation or particle bombardment, e.g. producing radioactive isotopes
    • G21G1/0005—Isotope delivery systems

Definitions

  • the field of the invention relates to nuclear medicine and more particularly, to methods of processing radioactive nuclides.
  • radioactive materials in nuclear medicine for therapeutic and diagnostic purposes are known.
  • radioactive material may be used to track blood flow for purposes of detecting obstructions or the like.
  • the radioactive material e.g., a tracer
  • the radioactive material may be injected into a vein of the arm or leg of a person.
  • a scintillation camera may be used to collect images of the person following the injection.
  • the gamma rays of the tracer interact with a detector of the camera to create images of the person.
  • a series of images are collected as the tracer perfuses through the person. Since the tracer diffuses through the blood of the person, the veins or arteries with greater blood flow produce a greater signature from the tracer.
  • radioactive material may be coupled at a molecular level with a biolocalization agent.
  • the biolocalization agent may concentrate the radioactive material at some specific location (e.g., the site of a tumor).
  • Radioactive materials Key to the use of radioactive materials in nuclear medicine is the creation of nuclear materials with a relatively short half life (e.g., 2-72 hours).
  • the short half life causes the radioactivity to decay rapidly in such as way as to reduce the exposure of the person to the radiation.
  • FIG. 1 is a block diagram of a system for generating radionuclides shown generally in accordance with an illustrated embodiment of the invention
  • FIGs. 2A-C are front, side and cut-away views of a product cartridge assembly for use with the system of FIG. 1;
  • FIGs. 3A-C are side, top and cut-away views of the product cartridge of FIGs. 2A-C;
  • FIGs. 4A-B are a side and side cutaway view of a product cartridge assembly under an alternate embodiment.
  • FIG. 1 is a block diagram of a separation system 10 used to separate radionuclides shown generally in accordance with an illustrated embodiment of the invention.
  • the system 10 may be used to provide highly pure radioactive materials for use in diagnostic or therapeutic processes.
  • the system 10 may be constructed as a portable device that is simple to use in radionuclide production facilities, nuclear pharmacies or in some other medical environment with various embodiments depending upon the isotope.
  • the system 10 may be used to separate a parent radionuclide from a daughter radionuclide using a forward COW process and where the daughter radionuclide is produced by the decay of the parent radionuclide.
  • the system 10 may also be used to separate a daughter radionuclide from a parent radionuclide using a reverse COW process.
  • the separation column 28 may be selected for purification of a wide range of
  • the separation columns 26, 36 may be filled within a chromatographic material (e.g., ion- exchange resin, extraction chomotographic material, etc.) targeted for the specific radionuclide needed.
  • the system 10 may be used for the purification of yttrium-90, bismuth-212 and 213, or rhenium- 188 for radiotherapy or technetium-99 m, thallium-201 , fluorine- 18 or indium- 111 for diagnostic imaging.
  • the system 10 may be provided with a parent radionuclide. After some period of time, some of the parent radionuclide will decay to produce a mixture of parent and daughter radionuclide.
  • a controller 34 of the system 10 may activate one or more valves 22, 24, 26 and a pump 30 to transport the mixture of the parent and daughter radionuclide from a parent container 12 to a first separation column 28 that captures the daughter radionuclide. Once the mixture of parent and daughter radionuclide has passed through the separation column 28, the remaining parent may be transported back to the container 12.
  • the controller 34 may wash the first separation column 28 by activating valves 22, 24 to first withdraw a wash solution from a processing fluids container 14, 16 and then to discard the wash solution into a waste container 18, 20.
  • the wash process may be repeated any of a number of times with the same or different types of wash solutions.
  • the controller 34 may withdraw a stripping solution from one of the processing fluids containers 14, 16 and then pump the stripping solution through the first separation column 28, through valve 26 and into the product cartridge assembly 32.
  • the stripping solution functions to release the daughter radionuclide from the separator column 28 and then transport the daughter radionuclide into the product cartridge assembly 32.
  • FIGs. 2A-C are front, side and cut-away views of the product cartridge assembly 32.
  • the product cartridge assembly 32 serves the very important purpose of protecting the environment from spillage of radioactive materials and users of the system 10 from radiation.
  • the product cartridge assembly 32 includes the product cartridge 42 and the cartridge adapter 44.
  • the cartridge adapter 44 may be semi-permanently attached to the housing of the system 10.
  • the product cartridge 42 is removable and replaceable.
  • FIGs. 3 A-C are side, top and cut-away views of the product cartridge 42.
  • the product cartridge 42 includes a filling assembly 70 with an upper housing 46 and a product container 68 with a lower housing 48.
  • the upper housing 46 and lower housing 48 may be constructed of polyethylene and operate as radiation shields for low energy particles.
  • the upper and lower housings 46, 48 Surrounding the upper and lower housings 46, 48 is a further upper radiation shield 50 and a lower radiation shield 52.
  • the upper and lower radiation shields may be made of lead.
  • the product container 68 contains a product vial 56 sealed with a permeable cap 58 within the lower housing 48.
  • the product vial 56 is filled via a projection (e.g., a syringe needle) 60 that penetrates the permeable cap 58.
  • the lower radiation shield 52 of the product container 68 may be provided with a reduced diameter coupler 54 that allows the product container 68 to be inserted or threaded into the filling assembly 70 as shown in FIG. 3A.
  • the coupler 54 allows the product vial 56 to be safely filled with a radionuclide and also for the product container 68 to be subsequently separated from the filling assembly 70 where the separated product container 68 includes with the shield 42 and product vial 56 as a single unit.
  • the needle 60 used for filling the product vial 56 is rigidly attached to the cartridge body 58.
  • a secondary filter with vent 62 is also included within the movable cartridge body 58, connected in series with the needle 60.
  • a particulate filter 64 is also included within the movable cartridge body 58, connected in series with the needle 60.
  • FIG. 3C shows the cartridge body 58 of the filling assembly 70 in an extended position with regard to the housing 46.
  • a user may grasp an external tab 72 and urge the movable cartridge body 58 upwards from the position shown in FIG. 3 A until the needle 60 dislodges from the cap 58.
  • the product container 68 may then be disconnected from the filling assembly 70.
  • a user may select an appropriate filling assembly 70 and product container 68 and engage the shield 52 of the product container 68 to the shield 50 of the filling assembly 70 via the coupling 54.
  • the user may apply a force 60 to the movable cartridge body 58 in order to move the cartridge body 58 downward sufficiently to cause the needle 60 to penetrate and extend through the cap 58.
  • the cartridge 32 may be installed into the system 10.
  • the cartridge 32 is assembled to the cartridge adapter 44.
  • a lever 74 (FIG. 2B) may be rotated from right to left. Rotation of the lever 74 causes a cam and cam follower attached to the lever 74 to move a male Lauer fitting downward and to advance into and engage the female portion of the connector 66.
  • FIGs. 4A and 4B depict a product cartridge assembly 100 under another illustrated embodiment.
  • the assembly includes a filling assembly 102 and a product cartridge 104.
  • the product filing assembly includes a tungsten case 106 that protects users from radiation.
  • the product cartridge includes a product vial 108 surrounded by a tungsten shield.
  • the product cartridge may be attached to the filling assembly via a threaded connection 112.
  • the filling assembly includes a moveable connection assembly or filling cartridge 114 that moves relative to the outside shield 106.
  • the connection assembly includes a filter assembly 116, a sanitary filter membrane 118 and a needle assembly 120.
  • the filter assembly includes a guard resin that acts as a scavenger for heavy metals (e.g., parent isotopes).
  • the needle assembly includes a hypodermic needle 122 that pierces a permeable cap 124 of the sterile product vial as the connection assembly is pressed downwards and simultaneously vents the container through an embodied sterility filter.
  • the filling assembly includes a radio frequency identification (RFID) tag 126.
  • RFID radio frequency identification
  • the filling assembly is intended for a one-time use.
  • the controller reads the RFID tag of the filling assembly and saves an identification number into memory as part of a tracking file for the finished product.
  • the controller also search for any previous use of the filling assembly and rejects the process if the filling assembly has been previously used.
  • connection assembly is connected to the separation system via a male Luer fitting 128.
  • a tab may be grasped by a user and rotated to seat the Luer fitting into a female Luer fitting on the separation system.
  • the product cartridge assembly includes a product vial having a permeable cap and surrounded by a radiation shield and a filling cartridge having a separate radiation shield, the filling cartridge is supported adjacent the permeable cap by coupling the radiation shield of the filling cartridge to the radiation shield of the product vial, the filling cartridge is moveable within the radiation shield of the filling cartridge to engage and pierce the permeable cap during filling of the product vial, the filling cartridge includes an aperture on an end opposite the product vial that receives a radionuclide, a scavenger that removes heavy metals from the radionuclide and a filter that filters the biological contaminants as the radionuclide flows from the aperture through the filling cartridge and into the product vial.
  • the product cartridge assembly includes an upper housing and a lower housing, the lower housing being coupled into the upper housing, the lower housing further including a shield that defines an outer surface of the lower housing, the shield substantially blocks radioactivity from the radionuclide, a product vial within the housing, the shield substantially surrounding the product vial and a cap on a top of the product vial, an upper surface of the cap being of a material that is easily pierced by a filling tubing, the upper housing further including, a shield that defines an outer surface of the upper housing, the shield substantially blocks radiation from the radionuclide, a filling cartridge having a closed top and bottom that slides within the upper housing from a retracted state and an active state, a receptacle disposed on the closed top with an aperture that extends from the receptacle through the closed top, a filling tube extending from the closed bottom, a proximal end of the filling tube extending through the closed bottom and a distal end of the filling tube residing in a

Landscapes

  • Physics & Mathematics (AREA)
  • Engineering & Computer Science (AREA)
  • General Engineering & Computer Science (AREA)
  • High Energy & Nuclear Physics (AREA)
  • Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

Cartouche de produit pour radionucléide comprenant un flacon de produit comportant un bouchon perméable et entouré d'un écran antiradiation et une cartouche de remplissage possédant un écran antiradiation distinct, la cartouche de remplissage étant supportée de manière adjacente au bouchon perméable par l'accouplement de l'écran antiradiation à l'écran antiradiation du flacon de produit, la cartouche de remplissage étant mobile dans l'écran antiradiation de la cartouche de remplissage pour entrer en prise avec le bouchon perméable et le percer durant le remplissage du flacon de produit, la cartouche de remplissage comprenant une ouverture sur une extrémité opposée au flacon de produit qui reçoit un radionucléide, un épurateur qui éliminer les métaux lourds du radionucléide et un filtre qui filtre les agents de contamination biologiques, mettant en même temps à l'air libre le flacon de produit quand le radionucléide s'écoule depuis l'ouverture jusque dans le flacon de produit en passant par la cartouche de remplissage.
PCT/US2014/063209 2013-10-30 2014-10-30 Cartouche de produit pour radionucléide Ceased WO2015066356A1 (fr)

Priority Applications (8)

Application Number Priority Date Filing Date Title
CN201480060079.5A CN105682705B (zh) 2013-10-30 2014-10-30 用于放射性核素的产品盒
DK14857442.9T DK3062840T3 (en) 2013-10-30 2014-10-30 RADIONUCLIDE PRODUCT PATTERN
CA2928837A CA2928837C (fr) 2013-10-30 2014-10-30 Cartouche de produit pour radionucleide
EP14857442.9A EP3062840B1 (fr) 2013-10-30 2014-10-30 Cartouche de produit pour radionucléide
KR1020167014448A KR102333352B1 (ko) 2013-10-30 2014-10-30 방사성 핵종을 위한 제품 카트리지
AU2014342231A AU2014342231B2 (en) 2013-10-30 2014-10-30 Product cartridge for radionuclide
JP2016552243A JP6657102B2 (ja) 2013-10-30 2014-10-30 放射性核種用の生成物カートリッジ
ZA2016/02674A ZA201602674B (en) 2013-10-30 2016-04-19 Product cartridge for radionuclide

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201361897501P 2013-10-30 2013-10-30
US61/897,501 2013-10-30

Publications (1)

Publication Number Publication Date
WO2015066356A1 true WO2015066356A1 (fr) 2015-05-07

Family

ID=53005134

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2014/063209 Ceased WO2015066356A1 (fr) 2013-10-30 2014-10-30 Cartouche de produit pour radionucléide

Country Status (10)

Country Link
US (1) US9336912B2 (fr)
EP (1) EP3062840B1 (fr)
JP (1) JP6657102B2 (fr)
KR (1) KR102333352B1 (fr)
CN (1) CN105682705B (fr)
AU (1) AU2014342231B2 (fr)
CA (1) CA2928837C (fr)
DK (1) DK3062840T3 (fr)
WO (1) WO2015066356A1 (fr)
ZA (1) ZA201602674B (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US12293848B2 (en) 2020-12-29 2025-05-06 BWXT Isotope Technology Group, Inc. Coaxial needle Technetium elution generator

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9327886B2 (en) * 2013-03-13 2016-05-03 Bayer Healthcare Llc Vial container with collar cap
US9757306B2 (en) 2013-03-13 2017-09-12 Bayer Healthcare Llc Vial container with collar cap
CN105682691B (zh) * 2013-10-30 2019-10-11 北极星医疗放射性同位素有限责任公司 用于处理和跟踪放射性核素的系统
JP7544819B2 (ja) 2019-12-05 2024-09-03 サイエンコンス アクスイェ セルスカプ 高度に精製された２１２Ｐｂの製造
CN111477374B (zh) * 2020-05-29 2024-08-23 成都纽瑞特医疗科技股份有限公司 一种封闭式操作放射性核素的容器及方法
EP4558211A2 (fr) 2022-07-19 2025-05-28 Northstar Medical Technologies LLC Raccord fluidique magnétique
WO2024118123A1 (fr) 2022-11-28 2024-06-06 NorthStar Medical Technologies, LLC Vanne rotative de dérivation inversée de rinçage propre

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US3397694A (en) * 1965-07-06 1968-08-20 C S M Corp Combination syringe package, syringe and chamber
US3446965A (en) * 1966-08-10 1969-05-27 Mallinckrodt Chemical Works Generation and containerization of radioisotopes
US3673411A (en) * 1970-03-03 1972-06-27 Nuclear Associates Inc Holder for radioactive material
US3902849A (en) * 1971-08-19 1975-09-02 Medi Physics Inc Radioisotope and radiopharmaceutical generators
US3993063A (en) * 1975-06-16 1976-11-23 Union Carbide Corporation Protective shielding assembly for use in loading a hypodermic syringe with radioactive material
US4307713A (en) * 1980-02-13 1981-12-29 Thomas Jefferson University Syringe shields and methods for using same
US4834149A (en) * 1987-07-07 1989-05-30 Survival Technology, Inc. Method of reconstituting a hazardous material in a vial, relieving pressure therein, and refilling a dosage syringe therefrom
US5927351A (en) * 1997-05-30 1999-07-27 Syncor International Corp. Drawing station system for radioactive material
US20080200747A1 (en) * 2005-05-16 2008-08-21 Wagner Gary S Radiopharmaceutical Pigs and Portable Powered Injectors
US20100329406A1 (en) * 2009-06-26 2010-12-30 General Electric Company Isotope production system with separated shielding
US7914766B1 (en) * 2004-06-03 2011-03-29 Ut-Battelle Llc Inorganic resins for clinical use of 213Bi generators
US20120289925A1 (en) * 2009-08-07 2012-11-15 Medtronic Minimed, Inc. Transfer guard systems and methods
US20120323210A1 (en) * 2010-02-24 2012-12-20 Medimop Medical Projects Ltd. Fluid transfer assembly with venting arrangement

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CN101184518A (zh) * 2005-05-16 2008-05-21 马林克罗特公司 放射性药物罐和便携动力注射器
CA2627429A1 (fr) * 2005-08-29 2007-12-27 Mallinckrodt Inc. Systeme et procede d'elution d'un radioisotope introduit dans un contenant dispose a l'exterieur d'un generateur de radioisotopes
ES2560665T3 (es) * 2005-10-03 2016-02-22 Mallinckrodt Llc Sistema y método radiofarmacéutico utilizando etiquetas de identificación por radiofrecuencia
US8348903B2 (en) * 2006-10-11 2013-01-08 Trasis S.A. Dispenser cartridge for radiopharmaceuticals
US8866104B2 (en) * 2011-01-19 2014-10-21 Mallinckrodt Llc Radioisotope elution system
KR101254549B1 (ko) * 2011-08-29 2013-04-19 한국원자력연구원 99ｍ-Ｔｃ 발생기용 칼럼 모듈, 시스템 및 이를 이용한 99ｍ-Ｔｃ 추출 방법

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Publication number Priority date Publication date Assignee Title
US3397694A (en) * 1965-07-06 1968-08-20 C S M Corp Combination syringe package, syringe and chamber
US3446965A (en) * 1966-08-10 1969-05-27 Mallinckrodt Chemical Works Generation and containerization of radioisotopes
US3673411A (en) * 1970-03-03 1972-06-27 Nuclear Associates Inc Holder for radioactive material
US3902849A (en) * 1971-08-19 1975-09-02 Medi Physics Inc Radioisotope and radiopharmaceutical generators
US3993063A (en) * 1975-06-16 1976-11-23 Union Carbide Corporation Protective shielding assembly for use in loading a hypodermic syringe with radioactive material
US4092546A (en) * 1975-06-16 1978-05-30 Union Carbide Corporation Protective shielding assembly for use in loading a hypodermic syringe with radioactive material
US4307713A (en) * 1980-02-13 1981-12-29 Thomas Jefferson University Syringe shields and methods for using same
US4834149A (en) * 1987-07-07 1989-05-30 Survival Technology, Inc. Method of reconstituting a hazardous material in a vial, relieving pressure therein, and refilling a dosage syringe therefrom
US5927351A (en) * 1997-05-30 1999-07-27 Syncor International Corp. Drawing station system for radioactive material
US7914766B1 (en) * 2004-06-03 2011-03-29 Ut-Battelle Llc Inorganic resins for clinical use of 213Bi generators
US20080200747A1 (en) * 2005-05-16 2008-08-21 Wagner Gary S Radiopharmaceutical Pigs and Portable Powered Injectors
US20100329406A1 (en) * 2009-06-26 2010-12-30 General Electric Company Isotope production system with separated shielding
US20120289925A1 (en) * 2009-08-07 2012-11-15 Medtronic Minimed, Inc. Transfer guard systems and methods
US20120323210A1 (en) * 2010-02-24 2012-12-20 Medimop Medical Projects Ltd. Fluid transfer assembly with venting arrangement

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US12293848B2 (en) 2020-12-29 2025-05-06 BWXT Isotope Technology Group, Inc. Coaxial needle Technetium elution generator

Also Published As

Publication number Publication date
KR102333352B1 (ko) 2021-12-01
EP3062840A1 (fr) 2016-09-07
AU2014342231A1 (en) 2016-05-12
CN105682705A (zh) 2016-06-15
AU2014342231B2 (en) 2019-05-23
CA2928837A1 (fr) 2015-05-07
JP6657102B2 (ja) 2020-03-04
DK3062840T3 (en) 2019-04-08
KR20160078485A (ko) 2016-07-04
US9336912B2 (en) 2016-05-10
JP2016537163A (ja) 2016-12-01
CA2928837C (fr) 2021-08-17
CN105682705B (zh) 2019-07-19
EP3062840B1 (fr) 2018-12-19
EP3062840A4 (fr) 2017-11-15
US20150123021A1 (en) 2015-05-07
ZA201602674B (en) 2017-07-26

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